Outcome of Embryo Culture at Two Oxygen Tensions

Embryo Development Clinical Trial

Official title:

Does Reduced Oxygen Tension in Embryo Culture Influence Clinical Outcome of ICSI Cycles? A Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00718822
• Other study ID #: P3-0327
• Status: Completed
• Phase: N/A
• First received: July 17, 2008
• Last updated: July 18, 2008
• Start date: August 2006
• Est. completion date: September 2007

Study information

• Verified date: July 2008
• Source: University Clinical Centre, Maribor
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess whether reduced oxygen tension in embryo culture has any effect on clinical outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 647
• Est. completion date: September 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 44 Years

Eligibility

Inclusion Criteria:

• stimulated Intra Cytoplasmic Sperm Injection (ICSI) cycle

Exclusion Criteria:

• less than one mature (metaphase II) oocyte at the time of denudation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Embryo Development

Intervention

Other:
• oxygen concentration in the culture atmosphere

Locations

Country	Name	City	State
Slovenia	University Clinical Centre Maribor	Maribor

Sponsors (2)

Lead Sponsor	Collaborator
University Clinical Centre, Maribor	Slovenian Research Agency

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate per cycle		10-11 weeks after embryo transfer	Yes
Secondary	clinical pregnancy rate, implantation rate, early pregnancy loss, fertilization rate, embryo quality			Yes